| Primary Device ID | 00884883007376 |
| NIH Device Record Key | 9982c5bf-e0c2-4997-a8a3-7854a487795b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays |
| Version Model Number | 10027480-U |
| Company DUNS | 122153799 |
| Company Name | Microgenics Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884883007376 [Primary] |
| OHQ | Multi-Analyte Controls Unassayed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-11 |
| Device Publish Date | 2021-11-03 |
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| 00884883007376 - MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays | 2021-11-11 |
| 00884883007376 - MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays | 2021-11-11 |
| 07613336190791 - OXY DRI Oxycodone | 2021-11-03 |
| 00884883007383 - MAS anti-HBs Positive Control – For use with Siemens Assays | 2021-05-13 |
| 00884883007765 - MAS SARS-CoV-2 IgG Positive Control | 2021-03-15 |
| 00884883007772 - MAS SARS-CoV-2 Negative Control | 2021-03-15 |